510(k) · Cleared
ClearedMicroplate Neonatal Galt Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Cleared on Apr 9, 1999 as substantially equivalent to K961432 (Bio-Rad, 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.
- Decided
- Apr 9, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- KQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961432 (1996). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK961432 Radias Galt TestBio-Rad · 1996
- This deviceK990827 Microplate Neonatal Galt AssayBio-Rad · 1999
- Descendant · cites it directly · 0 of its ownK102643 Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK090940 Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK993536 Bio-Rad Coda Neonatal Galt AssayBio-Rad · 1999
Most influential descendants
Showing 3 of 3 · See all- K102643Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011 · cites it directly0descendants
- K090940Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009 · cites it directly0descendants
- K993536Bio-Rad Coda Neonatal Galt AssayBio-Rad · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961432 | Radias Galt Test | Bio-Rad | 1996 | — |
| 0 (this device) | K990827 | Microplate Neonatal Galt Assay | Bio-Rad | 1999 | — |
| +1 | K102643 | Spotcheck Neonatal Galt Microplate Reagent Kit | Astoria-Pacific, Inc. | 2011 | — |
| +1 | K090940 | Spotcheck Blood Spot Control, Assayed | Astoria-Pacific, Inc. | 2009 | — |
| +1 | K993536 | Bio-Rad Coda Neonatal Galt Assay | Bio-Rad | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961432 | Radias Galt TestSummary page 1…ity Assurance Manager March 10, 1999 Microplate Neonatal GALT Class II, Galactose-1-phosphate uridyl transferase test system; 21 CFR 862.1315, 75KQP RADIAS GALT Assay K961432 Bio-Rad Laboratories Hercules, CA 94547 This assay is for the qualitative determination of galactose-1-phosphate uridyl transfe… | 1996 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KQP devicesKQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQP
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KQP
Too few KQP 510(k)s in any year since 2007 to give a median.
Recalls per year · KQP
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQP
No MAUDE report names KQP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in dried blood spot samples. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
For in vitro diagnostic use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990827 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990827: Microplate Neonatal Galt Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990827
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026